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    About

    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to co...
    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.

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    Robert J. Coury Global Center 1000 Mylan Blvd. Canonsburg, PA 15317
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “LGM Pharma has made significant strides in meeting the evolving needs of its clients”

    “LGM Pharma has made significant strides in meeting the evolving needs of its clients”

    This week, SpeakPharma interviews four senior executives of LGM Pharma — Shailesh Vengurlekar (Senior VP, Quality and Regulatory Affairs), Deepak Thassu (Senior VP, R&D and Regulatory Submission), Selwyn Lustman (Senior VP, Global Sourcing and Procurement), and Mike Stenberg (VP, Business Development). The four VPs talk about expansion in manufacturing capabilities of the Florida-based contract development and manufacturing organization (CDMO), expertise that makes LGM a strong partner and the criteria it adopts while selecting its suppliers.  HIGHLIGHTS// expansion in manufacturing capabilities/ expertise that makes LGM a strong partner/ criteria for selecting its suppliers LGM Pharma recently invested heavily in expanding its CDMO capabilities by 50 percent. Can you share why offering standalone analytical testing services is important to LGM Pharma’s growth strategy? How does it benefit your clients? Vengurlekar: This recent expansion in CDMO capabilities is part of LGM Pharma’s growth strategy that lays importance on diversification. One key area of this diversification is the offering of standalone Analytical Testing Services (ATS). This service plays a crucial role in supporting our clients by providing them with greater flexibility and reliability. LGM Pharma is already a well-established leader in the API supply chain. We have now identified a significant need in the market and are now serving compounding pharmacies, including 503A and 503B facilities. These pharmacies not only require high-quality, GMP-compliant APIs, but also need a trusted, compliant, and capable laboratory to analyze both their APIs and compounded products. Recognizing this opportunity to further support our clients, LGM Pharma has expanded into ATS. We have witnessed tremendous growth since we’ve launched these services. By offering ATS under a separate legal entity — LGM Pharma Solutions — we are able to provide an additional layer of flexibility to our clients. This structure eliminates any conflict of interest. While LGM Pharma LLC handles API supply, LGM Pharma Solutions focuses on delivering top-tier ATS, all under the same LGM Pharma umbrella. This setup enhances trust and allows our clients to work with us more seamlessly. HIGHLIGHTS// diversified into standalone ATS/ well-established leader in API supply chain/ serving compounding pharmacies/ offering APIs and ATS under different legal entities. While suppositories offer clear advantages for certain medications, can you describe how LGM Pharma plans to leverage its expertise in this area to address specific unmet needs in the growing women’s health market? Thassu: We’re taking a dual approach to enhance both our R&D and manufacturing capabilities. First, we’ve introduced a new semi-automatic machine that allows us to produce smaller batches more efficiently. This is particularly important for the suppository segment, where demand doesn’t require large-scale production. The new system enables quicker adjustments to the manufacturing process, providing us with greater flexibility of producing small batches. Second, many of the materials we handle in the women’s health sector are sensitive to heat, light, and oxygen. To address this, we’re upgrading our facility to accommodate these specialized requirements. This ensures we can develop and manufacture products while maintaining the integrity of heat-, light-, and oxygen-sensitive ingredients. Additionally, we’re working closely with clients to prepare for various technical challenges. Whether it’s processing homeopathic ingredients or handling delicate fermentation-based materials, which are highly sensitive to both light and heat, our team has upgraded its skills and equipment to manage these complexities. From technology advancements in manufacturing to specialized handling conditions and improved technical expertise, we’ve made significant strides to ensure we can meet the evolving needs of our clients and their products. HIGHLIGHTS// dual approach to enhance R&D and manufacturing capabilities/ upgrading facilities to accommodate specialized requirements/ working with clients to address challenges. The pandemic underscored supply chain problems. Can you detail the specific criteria LGM Pharma uses while selecting suppliers for its manufacturing processes? Lustman: LGM looks at many facets of a manufacturer before proceeding to approve them for a specific project. We start by checking their regulatory history with the US Food and Drug Administration (FDA) and other authorities. We try to find out if they have received any warning letters. What is their inspection history? Have they received NAIs (no action indicated) and VAIs (voluntary action indicated)? We further investigate the company’s overall business status — we need to know that they are a stable partner to work with in the long term. Manufacturers are then assessed for their overall technology and the number of employees working in various fields, such as R&D, quality control, quality assurance, regulatory affairs, manufacturing, and the educational levels of these employees. Once we have established that the manufacturer is a potential partner, we check their status for a particular project. We look at their advantages, and whether they have a non-infringing route of synthesis (ROS) that will allow early launch. Are they developing a second process that will be more competitive in pricing? And, does the manufacturer have the necessary capacity and/or spare capacity for the project that we are assessing? We need to know whether the drug master file (DMF) has been registered, the current batch size, and the potential for increase in batch size. Pricing is a key indicator — we need to know whether the pricing of the manufacturer is competitive or not, and if the manufacturer will be able to compete in the future as the project matures. LGM always assesses for quality, price, and delivery. Goods must be of the correct quality, at the right price, with delivery time as desired, in order to meet commercial needs. HIGHLIGHTS// investigate various facets of manufacturer before approving them for a project/ look at advantages, non-infringing ROS/ assess for quality, price, delivery Can you highlight specific capabilities and experiences LGM Pharma possesses that make it a strong partner for companies developing antibody-drug-conjugates (ADCs)? Stenberg: ADCs are often peptides linked with small molecules. However, they may also be peptides linked with oligonucleotides. Regardless, LGM can help manage the supply chain associated with the components that are used in the conjugation of the ADC. LGM has extensive experience, and an extensive network around sourcing and managing the supply chain associated with ADC components. LGM’s experience and capabilities extend to sourcing peptides, small molecules or oligonucleotides used in the conjugation process. Additionally, given our deep relationships in the supply chain aspect of this process, LGM may also be able to identify partners who can help with the conjugation process itself. HIGHLIGHTS// extensive experience, network around sourcing, managing supply chain associated with ADC components / identify partners that can help with conjugation process

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    09 Nov 2024
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    DATA COMPILATION #PharmaFlow

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    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024.  Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent.  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each.  The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders).  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available)    GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453   US$ 3,21,920   Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427   US$ 2,31,952 FDF—Foreign US$ 2,35,427   US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629   US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852   US$ 7,56,666 Small business generic drug applicant US$ 1,72,963   US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.   
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    24 Oct 2024
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    NEWS #PharmaBuzz

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    Viatris Reports Q3 Financial Results for 2024
    Viatris Reports Q3 Financial Results for 2024

    07 Nov 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/viatris-reports-third-quarter-financial-results-for-2024-302298689.html

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    07 Nov 2024
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    Viatris Announces Q32024 Dividend
    Viatris Announces Q32024 Dividend

    05 Nov 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/viatris-announces-third-quarter-2024-dividend-302296180.html

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    05 Nov 2024
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    Viatris Named to Forbes' World's Top Companies for Women 2024 List
    Viatris Named to Forbes' World's Top Companies for Women 2024 List

    29 Oct 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/viatris-named-to-forbes-worlds-top-companies-for-women-2024-list-302290273.html

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    29 Oct 2024
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    Viatris To Participate In UBS And Jefferies Healthcare Conferences
    Viatris To Participate In UBS And Jefferies Healthcare Conferences

    29 Oct 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/viatris-to-participate-in-the-ubs-global-healthcare-conference-and-jefferies-london-healthcare-conference-302290043.html

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    29 Oct 2024
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    Lexicon Announces Licensing Agreement With Viatris For Sotagliflozin
    Lexicon Announces Licensing Agreement With Viatris For Sotagliflozin

    16 Oct 2024

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2024/10/16/2964507/0/en/Lexicon-Announces-Exclusive-Licensing-Agreement-With-Viatris-for-Sotagliflozin-in-All-Markets-Outside-of-the-U-S-and-Europe.html

    GLOBENEWSWIRE
    16 Oct 2024
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    Viatris Announces Licenses Sotagliflozin Outside U.S. And Europe
    Viatris Announces Licenses Sotagliflozin Outside U.S. And Europe

    16 Oct 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/viatris-announces-exclusive-licensing-agreement-with-lexicon-pharmaceuticals-for-sotagliflozin-in-all-markets-outside-of-the-us-and-europe-302278473.html

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    16 Oct 2024
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    Amlodipine besilate, Process C

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    Certificate Numbers : R0-CEP 2007-306 - Rev 02

    Status : Withdrawn by Holder

    Issue Date : 2011-11-08

    Type : Chemical

    Substance Number : 703

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    Certificate Numbers : R0-CEP 2017-008 - Rev 01

    Status : Withdrawn by Holder

    Issue Date : 2019-12-18

    Type : Chemical

    Substance Number : 369

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    Certificate Numbers : R0-CEP 2013-359 - Rev 01

    Status : Withdrawn by Holder

    Issue Date : 2017-09-27

    Type : Chemical

    Substance Number : 2762

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    Certificate Numbers : R1-CEP 2010-001 - Rev 03

    Status : Withdrawn by Holder

    Issue Date : 2019-08-13

    Type : Chemical

    Substance Number : 1089

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    Ciprofloxacin Hydrochloride

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    Certificate Numbers : R0-CEP 2016-082 - Rev 01

    Status : Withdrawn by Holder

    Issue Date : 2019-12-18

    Type : Chemical

    Substance Number : 1691

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    Certificate Numbers : R0-CEP 2012-176 - Rev 02

    Status : Withdrawn by Holder

    Issue Date : 2017-09-18

    Type : Chemical

    Substance Number : 712

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    ABACAVIR SULFATE

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    ABACAVIR SULFATE

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    NDC Package Code : 65015-640

    Start Marketing Date : 2015-02-13

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    NDC Package Code : 65015-600

    Start Marketing Date : 2015-01-20

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    ALENDRONATE SODIUM

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    NDC Package Code : 65015-683

    Start Marketing Date : 2015-02-13

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    ALLOPURINOL

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    NDC Package Code : 65015-606

    Start Marketing Date : 2015-02-12

    End Marketing Date : 2024-12-31

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    Marketing Category : BULK INGREDIENT

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    ALMOTRIPTAN MALATE

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    ALMOTRIPTAN MALATE

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    NDC Package Code : 65015-673

    Start Marketing Date : 2015-01-20

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    ALPRAZOLAM

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    ALPRAZOLAM

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    Viatris

    NDC Package Code : 65015-634

    Start Marketing Date : 2015-01-20

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    07

    AMBRISENTAN

    U.S.A
    Compamed
    Not Confirmed
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    AMBRISENTAN

    U.S.A
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    Viatris

    NDC Package Code : 65015-793

    Start Marketing Date : 2015-02-12

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    08

    AMLODIPINE BESYLATE

    U.S.A
    Compamed
    Not Confirmed
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    AMLODIPINE BESYLATE

    U.S.A
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    Not Confirmed
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    Viatris

    NDC Package Code : 65015-670

    Start Marketing Date : 2015-01-20

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    09

    AMLODIPINE BESYLATE

    U.S.A
    Compamed
    Not Confirmed
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    AMLODIPINE BESYLATE

    U.S.A
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    Not Confirmed
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    Viatris

    NDC Package Code : 65427-003

    Start Marketing Date : 2014-07-03

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    10

    APIXABAN

    U.S.A
    Compamed
    Not Confirmed
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    APIXABAN

    U.S.A
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    Not Confirmed
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    Viatris

    NDC Package Code : 65015-897

    Start Marketing Date : 2020-08-12

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    5-Fluorocytosine

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    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable oper...
    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.
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    01

    5-Fluorocytosine

    U.S.A
    Compamed
    Not Confirmed
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    5-Fluorocytosine

    U.S.A
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    Viatris

    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.

    About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) i...

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    Abacavir Sulfate

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    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable oper...
    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.
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    02

    Abacavir Sulfate

    U.S.A
    Compamed
    Not Confirmed
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    Abacavir Sulfate

    U.S.A
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    Viatris

    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.

    About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) i...

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    Abaloparatide

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    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable oper...
    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.
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    03

    Abaloparatide

    U.S.A
    Compamed
    Not Confirmed
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    Abaloparatide

    U.S.A
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    Compamed
    Not Confirmed
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    Viatris

    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.

    About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) i...

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    Abametapir

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    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable oper...
    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.
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    04

    Abametapir

    U.S.A
    Compamed
    Not Confirmed
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    Abametapir

    U.S.A
    arrow
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    Viatris

    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.

    About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) i...

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    Abemaciclib

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    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable oper...
    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.
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    05

    Abemaciclib

    U.S.A
    Compamed
    Not Confirmed
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    Abemaciclib

    U.S.A
    arrow
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    Not Confirmed
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    Viatris

    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.

    About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) i...

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    Acyclovir

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    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable oper...
    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.
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    06

    Acyclovir

    U.S.A
    Compamed
    Not Confirmed
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    Acyclovir

    U.S.A
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    Not Confirmed
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    Viatris

    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.

    About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) i...

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    Adenine

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    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable oper...
    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.
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    07

    Adenine

    U.S.A
    Compamed
    Not Confirmed
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    Adenine

    U.S.A
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    Viatris

    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.

    About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) i...

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    Adrenaline

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    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable oper...
    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.
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    08

    Adrenaline

    U.S.A
    Compamed
    Not Confirmed
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    Adrenaline

    U.S.A
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    Viatris

    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.

    About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) i...

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    Alprazolam

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    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable oper...
    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.
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    09

    Alprazolam

    U.S.A
    Compamed
    Not Confirmed
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    Alprazolam

    U.S.A
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    Viatris

    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.

    About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) i...

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    Ambrisentan

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    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable oper...
    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.
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    10

    Ambrisentan

    U.S.A
    Compamed
    Not Confirmed
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    Ambrisentan

    U.S.A
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    Viatris

    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.

    About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) i...

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    FDA Orange Book

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    01

    Brand Name : ABACAVIR SULFATE

    China
    The Pharmacy Technology
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE

    China
    The Pharmacy Technology
    Not Confirmed
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    RLD :

    TE Code :

    ABACAVIR SULFATE

    MATRIX LABORATORIES XIAMEN LTD.

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE

    Dosage Strength : 300MG

    Approval Date :

    Application Number : 78742

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    02

    Brand Name : ABACAVIR SULFATE

    U.S.A
    The Pharmacy Technology
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE

    U.S.A
    The Pharmacy Technology
    Not Confirmed
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    RLD : No

    TE Code : AB

    ABACAVIR SULFATE

    Viatris

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE

    Dosage Strength : EQ 300MG BASE

    Approval Date : 2012-06-18

    Application Number : 91294

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    03

    Brand Name : ABACAVIR SULFATE

    U.S.A
    The Pharmacy Technology
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE

    U.S.A
    The Pharmacy Technology
    Not Confirmed
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    RLD :

    TE Code :

    ABACAVIR SULFATE

    Viatris

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE

    Dosage Strength : 60 MG

    Approval Date :

    Application Number : 200733

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    Market
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    04

    Brand Name : ABACAVIR SULFATE; LA...

    U.S.A
    The Pharmacy Technology
    Not Confirmed
    arrow

    Brand Name : ABACAVIR SULFATE; LA...

    U.S.A
    The Pharmacy Technology
    Not Confirmed
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    • EDQM
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    RLD :

    TE Code :

    ABACAVIR SULFATE; LAMIVUDINE

    Viatris

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE; LAMIVU...

    Dosage Strength : 600MG; 300MG

    Approval Date :

    Application Number : 90519

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    Market
    Place

    05

    Brand Name : ABACAVIR SULFATE; LA...

    U.S.A
    The Pharmacy Technology
    Not Confirmed
    arrow

    Brand Name : ABACAVIR SULFATE; LA...

    U.S.A
    The Pharmacy Technology
    Not Confirmed
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    • EDQM
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    RLD :

    TE Code :

    ABACAVIR SULFATE; LAMIVUDINE

    Viatris

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE; LAMIVU...

    Dosage Strength : 60MG; 30MG

    Approval Date :

    Application Number : 202381

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    Market
    Place

    06

    Brand Name : ABACAVIR SULFATE, LA...

    U.S.A
    The Pharmacy Technology
    Not Confirmed
    arrow

    Brand Name : ABACAVIR SULFATE, LA...

    U.S.A
    The Pharmacy Technology
    Not Confirmed
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    RLD :

    TE Code :

    ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

    Viatris

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE, LAMIVU...

    Dosage Strength : EQ 300MG BASE; 150MG; 30...

    Approval Date :

    Application Number : 90309

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    Market
    Place

    07

    Brand Name : EPZICOM

    U.S.A
    The Pharmacy Technology
    Not Confirmed
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    Brand Name : EPZICOM

    U.S.A
    The Pharmacy Technology
    Not Confirmed
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    RLD :

    TE Code :

    ABACAVIR; LAMIVUDINE

    Viatris

    Dosage Form : TABLET; ORAL

    Proprietary Name : EPZICOM

    Dosage Strength : 600MG;300MG

    Approval Date :

    Application Number : 204004

    RX/OTC/DISCN :

    RLD :

    TE Code :

    blank

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    Market
    Place

    08

    Brand Name : ABACAVIR AND LAMIVUD...

    U.S.A
    The Pharmacy Technology
    Not Confirmed
    arrow

    Brand Name : ABACAVIR AND LAMIVUD...

    U.S.A
    The Pharmacy Technology
    Not Confirmed
    arrow
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    RLD :

    TE Code :

    ABACAVIR; LAMIVUDINE

    Viatris

    Dosage Form : TABLET; ORAL SUSPENSION

    Proprietary Name : ABACAVIR AND LAMIVUDINE

    Dosage Strength : 120MG;60MG

    Approval Date :

    Application Number : 204915

    RX/OTC/DISCN :

    RLD :

    TE Code :

    blank

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    Market
    Place

    09

    Brand Name : ABIRATERONE ACETATE

    U.S.A
    The Pharmacy Technology
    Not Confirmed
    arrow

    Brand Name : ABIRATERONE ACETATE

    U.S.A
    The Pharmacy Technology
    Not Confirmed
    arrow
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    RLD : No

    TE Code : AB

    ABIRATERONE ACETATE

    Viatris

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABIRATERONE ACETATE

    Dosage Strength : 250MG

    Approval Date : 2018-10-31

    Application Number : 208446

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Market
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    10

    Brand Name : ABIRATERONE ACETATE

    U.S.A
    The Pharmacy Technology
    Not Confirmed
    arrow

    Brand Name : ABIRATERONE ACETATE

    U.S.A
    The Pharmacy Technology
    Not Confirmed
    arrow
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    RLD : No

    TE Code : AB

    ABIRATERONE ACETATE

    Viatris

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABIRATERONE ACETATE

    Dosage Strength : 500MG

    Approval Date : 2020-12-14

    Application Number : 208446

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Market
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    Only 10 entries up to this point, click to access all click full view read-more
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    Europe

    read-more
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    01

    Brand Name : Idarubicin

    U.S.A
    Compamed
    Not Confirmed
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    Brand Name : Idarubicin

    U.S.A
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    Compamed
    Not Confirmed
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    Regulatory Info :

    Registration Country : Italy

    4-Demethoxydaunomycin

    Viatris

    Dosage Form : Idarubicin 10Mg 10Ml 1 Units P...

    Dosage Strength : 1 vial EV 10 mg/10 ml

    Packaging :

    Brand Name : Idarubicin

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

    blank

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    Market
    Place

    02

    Brand Name : Abirateron Viatris

    U.S.A
    Compamed
    Not Confirmed
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    Brand Name : Abirateron Viatris

    U.S.A
    arrow
    Compamed
    Not Confirmed
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    Regulatory Info :

    Registration Country : Switzerland

    Abirateroni acetas

    Viatris

    Dosage Form : Filmtabl

    Dosage Strength : 1000mg

    Packaging :

    Brand Name : Abirateron Viatris

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Market
    Place

    03

    Brand Name : Abirateron Viatris

    U.S.A
    Compamed
    Not Confirmed
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    Brand Name : Abirateron Viatris

    U.S.A
    arrow
    Compamed
    Not Confirmed
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    Regulatory Info :

    Registration Country : Switzerland

    Abirateroni acetas

    Viatris

    Dosage Form : Filmtabl

    Dosage Strength : 500mg

    Packaging :

    Brand Name : Abirateron Viatris

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Market
    Place

    04

    Brand Name : Mucomyst

    U.S.A
    Compamed
    Not Confirmed
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    Brand Name : Mucomyst

    U.S.A
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    Compamed
    Not Confirmed
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    Regulatory Info :

    Registration Country : Norway

    Acetylcystein

    Viatris

    Dosage Form : Inhalation liquid for nebulize...

    Dosage Strength : 200 mg/ml

    Packaging : Vials 10 10ml

    Brand Name : Mucomyst

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    Market
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    05

    Brand Name : Mucomyst

    U.S.A
    Compamed
    Not Confirmed
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    Brand Name : Mucomyst

    U.S.A
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    Compamed
    Not Confirmed
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    Regulatory Info :

    Registration Country : Norway

    Acetylcystein

    Viatris

    Dosage Form : Inhalation liquid for nebulize...

    Dosage Strength : 200 mg/ml

    Packaging : Vials 1 10ml

    Brand Name : Mucomyst

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    06

    Brand Name : Mucomyst

    U.S.A
    Compamed
    Not Confirmed
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    Brand Name : Mucomyst

    U.S.A
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    Compamed
    Not Confirmed
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    Regulatory Info :

    Registration Country : Norway

    Acetylcystein

    Viatris

    Dosage Form : Effervescent tablet

    Dosage Strength : 200 mg

    Packaging : Plastic pipe 25...

    Brand Name : Mucomyst

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    Market
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    07

    Brand Name : Mucomyst

    U.S.A
    Compamed
    Not Confirmed
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    Brand Name : Mucomyst

    U.S.A
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    Compamed
    Not Confirmed
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    Regulatory Info :

    Registration Country : Norway

    Acetylcystein

    Viatris

    Dosage Form : Effervescent tablet

    Dosage Strength : 200 mg

    Packaging : Plastic pipe 4 2...

    Brand Name : Mucomyst

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    Market
    Place

    08

    Brand Name : Mucomyst

    U.S.A
    Compamed
    Not Confirmed
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    Brand Name : Mucomyst

    U.S.A
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    Compamed
    Not Confirmed
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    Regulatory Info :

    Registration Country : Norway

    Acetylcystein

    Viatris

    Dosage Form : Inhalation liquid for nebulize...

    Dosage Strength : 200 mg/ml

    Packaging : Vials 5 10ml

    Brand Name : Mucomyst

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    Market
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    09

    Brand Name : ACETYLSALICYLIC ACID...

    U.S.A
    Compamed
    Not Confirmed
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    Brand Name : ACETYLSALICYLIC ACID...

    U.S.A
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    Compamed
    Not Confirmed
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    Regulatory Info :

    Registration Country : Italy

    Acetylsalicylic acid

    Viatris

    Dosage Form : Gastro-Resistant Tablets

    Dosage Strength : 100 mg

    Packaging : 30 UNITS 100 MG - ...

    Brand Name : ACETYLSALICYLIC ACID MYLAN

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Market
    Place

    10

    Brand Name : Cyclokapron

    U.S.A
    Compamed
    Not Confirmed
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    Brand Name : Cyclokapron

    U.S.A
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    Compamed
    Not Confirmed
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    Regulatory Info :

    Registration Country : Switzerland

    Acidum tranexamicum

    Viatris

    Dosage Form : Tabl

    Dosage Strength : 500mg

    Packaging :

    Brand Name : Cyclokapron

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Market
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    Only 10 entries up to this point, click to access all click full view read-more
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    Excipients

    Click here to find the perfect excipient manufacturers by their capabilities

    All Excipients

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    01

    Mannitol

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Compamed
    Not Confirmed
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    Mannitol

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Compamed
    Not Confirmed
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38630

    Submission : 2023-08-21

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    02

    Salcaprozate Sodium Excipient

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Compamed
    Not Confirmed
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    Salcaprozate Sodium Excipient

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Compamed
    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37682

    Submission : 2022-12-02

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    03

    POLYOLPREPOLYMER -02

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Compamed
    Not Confirmed
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    POLYOLPREPOLYMER -02

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Compamed
    Not Confirmed
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 22569

    Submission : 2009-02-23

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    04

    TRIETHYLAMMONIUM SUCROSE OCTASULFAT...

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Compamed
    Not Confirmed
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    TRIETHYLAMMONIUM SUCROSE OCTASULFAT...

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Compamed
    Not Confirmed
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37813

    Submission : 2023-03-28

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    05

    BERTEK CODE 44119 MEDILAM 3600

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Compamed
    Not Confirmed
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    BERTEK CODE 44119 MEDILAM 3600

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Compamed
    Not Confirmed
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 11884

    Submission : 1996-03-04

    Status : Inactive

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    06

    PIB ADHESIVE

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Compamed
    Not Confirmed
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    PIB ADHESIVE

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Compamed
    Not Confirmed
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14785

    Submission : 2000-03-16

    Status : Inactive

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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